BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z

    MDR report key: 2024337 · Received March 18, 2011

    Report

    Report Number
    2649622-2011-04113
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED 22 DAYS FOLLOWING IMPLANT OF PACEMAKER. FOLLOW UP WITH CLINIC REPORTED PATIENT HAD LAST BEEN SEEN THERE TEN DAYS AFTER IMPLANT AND THERE WERE NO DEVICE OR LEAD ISSUES AT THAT TIME. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death